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This is an example of a patient single item visual analog scale (VAS) - used to assess the level of craving based on response to the question “ In the past 24 hours, how strong is your craving for cigarettes?” on a scale from “no craving” to “strong craving” by measuring the number of millimeters (0–100 mm) from the “no craving” dot to the point at which the drawn line intersected the scale.

The Findings About Events or Interventions (FA) domain was used for tp represent  the assessment of craving. Sponsors may represent findings data in a single FA dataset or split the FA domain into separate datasets, following the guidance in the SDTMIGsection Use of Relative Timing Variables (Copy). In this example, an a FACE dataset was used. The craving itself is considered a clinical event, whereas the evaluation of craving at specific time points are considered findings about the clinical event.  A parent record in the CE domain is not required.

This example illustrates how information on the scale scoring may be represented as supplemental supplemental qualifier variables.   A record in a SUPPFA  dataset relates back to its parent record(s) via the key identified by the STUDYID, RDOMAIN, USUBJID, and IDVAR/IDVARVAL variables. Here the parent domain (RDOMAIN) is FA, and IDVAR is FASEQ. QNAM holds the name of the supplemental qualifier variable being defined.